Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006313979

FEI Number

3006313979

Entity Name

Innovative BioCeramix, Inc

City/State/Country

Burnaby British Columbia, CA

Establishment Address

101 - 8218 North Fraser Way, Burnaby British Columbia V3N 0E9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNOVATIVE BIOCERAMIX INC. (Owner Number: 9089383)

Owner / Operator Contact Address

101 - 8218 North Fraser Way, --, Burnaby, CA-BC V3N 0E9, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102867

PMA Number

N/A

All Registered Proprietary Names

iRoot FM EndoSequence BC RRM 1.5G 2P EndoSequence BC RRM 1G 1P TotalFill BC RRM 1G 1P TotalFill BC Sealer 1.5G 1P EndoSequence BC Sealer HiFlow 1.5G 2P TotalFill BC Sealer 2G 1P EdgeBioceramic Sealer 2g EndoSequence BC Sealer HiFlow 1.5G 1P EndoSequence BC Sealer Trial Pack EdgeBioceramic ThermalFlow 1.5g EndoSequence BC Sealer 2G 1P EndoSequence BC Sealer 1.6G 2P TotalFill BC Sealer HiFlow 1.5G 1P BC Tips 15P EndoSequence BC RRM Putty 3G 1P EndoSequence BC RRM Putty .5G EdgeBioceramic RetroFill and Perforation Repair Material .5g TotalFill BC RRM Putty 2.5G 1P EndoSequence BC Pediatric Putty .5g 1P EndoSequence BC RRM Fast Set Putty 1P EndoSequence BC Pediatric Putty .5g 6P TotalFill BC RRM Fast Set Putty 1P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2014-12-15
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2009-02-03
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2008-04-14
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2024-08-22
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2009-11-24
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2011-12-05

Official Correspondent

QUANZU YANG

US Agent Details

Jim MacNee Business: USDeviceAgent.com Email: Jmacnee@USDeviceAgent.com Phone: (951) 8486626

Related Public Records

Same Entity

INNOVATIVE BIOCERAMIX INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3003449480	VERICOM CO., LTD.	Chuncheon-Si Gangwon, KR
3030405669	ODNE AG	Dubendorf Zurich, CH
3031606505	ENPUNO BIOTECHNOLOGY CO., LTD	Changsha Hunan, CN
3006542438	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS	LONDRINA Parana, BR
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006313979. Last updated year: 2026. Please use registration number 3006313979 when referencing this establishment in official correspondence.